[Remote] Contract, Clinical Operations at Axsome Therapeutics Inc

United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

BiopharmaceuticalIndustries

Requirements

A Bachelor's degree in a scientific or healthcare-related field is required. The role demands expertise in leading the execution of clinical trials throughout their lifecycle, adhering to regulatory requirements. Experience in managing clinical trial timelines, budgets, and vendor relationships is essential.

Responsibilities

The Contract, Clinical Operations role involves planning, executing, and reporting on clinical trials, including protocol writing, CRF design, site selection, and CRO management. Responsibilities include interacting with internal and external teams to develop clinical strategies, evaluating scientific literature, writing study protocols and related documents, negotiating contracts, planning investigator meetings, and managing clinical study timelines and budgets. The role also facilitates regulatory submissions, reviews clinical trial data for accuracy, and resolves site and monitor queries.

Skills

Clinical Trial Management

Protocol Writing

CRF Design

Site Selection

CRO Management

Data Review

Study Reporting

Regulatory Requirements

SOP Adherence

Clinical Operations

Axsome Therapeutics Inc

Develops therapies for CNS disorders

About Axsome Therapeutics Inc

Axsome Therapeutics develops therapies for central nervous system (CNS) disorders, focusing on conditions like major depressive disorder, treatment-resistant depression, and Alzheimer's agitation. Their main product, AXS-05, is an oral medication that works by blocking NMDA receptors in the brain, which helps regulate mood. This drug has shown positive results in clinical trials and has received special FDA status to speed up its approval process. Unlike many competitors, Axsome emphasizes addressing unmet medical needs in CNS disorders and aims to improve patient outcomes through rigorous research and development. The company's goal is to bring effective treatments to market, enhancing the quality of life for patients suffering from these conditions.

New York City, New YorkHeadquarters

2012Year Founded

$430.7MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Performance Bonus

Company Equity

Risks

Increased competition from companies like Compass Pathways in the CNS market.

Potential delays in AXS-07 launch amid growing market anticipation.

Departure of key personnel like Lori Englebert may impact strategic direction.

Differentiation

Axsome focuses on CNS disorders with limited current treatment options.

AXS-05, an NMDA receptor antagonist, targets major depressive disorder and treatment-resistant depression.

Axsome's balanced portfolio includes both clinical and research stage products.

Upsides

FDA's fast-tracking of CNS treatments could expedite Axsome's drug approvals.

Increased investment in CNS R&D drives innovation, benefiting Axsome's pipeline.

Growing personalized medicine trend offers Axsome opportunities for tailored therapies.

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